|Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.|
|Trade Name||ADEZA FETAL FIBRONECTIN EIK|
|Classification Name||enzyme immunoassay, fetal fibronectin|
|Supplement Type||normal 180 day track|
|Supplement Reason|| labeling change - indications|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a modification of the intended use statement as follows: "the device is further indicated for use in conjunction with other clinical info as an aid in assessing the risk of preterm delivery in < 34 weeks, 6 days when a cervicovaginal sample is obtained during a routine prenatal visit between 22 weeks, 0 days and 30 weeks, 6 days of gestation in women with a singleton gestation. The positive predictive value ranges from 13. 3% to 31. 7% for delivery in < 34 weeks, 6 days and represents an approximate 4- to 7-fold increase in risk over the reliability of predicting delivery given no test info. The negative predictive value ranges from 96. 4% to 97. 9% making it highly likely that delivery will not occur in these time frames. ".